Currently, HD (hemodialysis) and vascular access for chemotherapy and plasmapheresis is achieved in one of several ways. Applicant's invention involves a new method and instrumentation for HD and vascular access designed to eliminate the problems of the prior methods and create a new, more durable, easier to use, vascular access system.
One prior art method involves a primary arteriovenous fistula. In this method, a native artery is sewn to a native vein creating a high flow system of blood in a vein which over time can be accessed with two hemodialysis needles attached to a dialysis machine. The problem with this method is that few patients are candidates secondary to anatomy and in others the veins or shunt fail to enlarge and mature properly even if the primary fistula remains patent. These arteriovenous fistulas also become aneursymbol over time requiring revision.
Another method involves a subcutaneous prosthetic conduit (PTFE) in the shape of a tube which is sewn at either end to openings made in an artery and vein. This method causes recurrent stenosis at the venous outflow leading to thrombosis (i.e., graft closure) secondary to intimal hyperplasia at venous anastomosis. Thrombosis also occurs at needle puncture sites along the PTFE.
Another method involves a “tunneled” percutaneous dual lumen catheter which is inserted into a central vein. This causes recurrent thrombosis secondary to stasis of blood in the lumen (i.e., not a continuous flow system like an A-V fistula) and build up of fibrinous debris at the venous end. Further, the access end of the catheter protrudes through the skin making it cosmetically unappealing, cumbersome to live with, as well as more likely to become infected.
A further method involves the use of the Sorenson Catheter. This is a percutaneous (not tunneled) dual lumen catheter, placed into the central venous system, which is used to provide temporary access for the purposes of hemodialysis. These catheters are prone to kinking, clotting, infection, and poor flow rates.
A still further method of vascular access involves the “Porta-a-cath”. This system of venous access, which utilizes a subcutaneous reservoir attached to a central venous catheter, is used for long term intervenous access for chemotherapy etc. (It is not intended for HD.) The ports are prone to clotting and must be continually flushed since they are a stagnant system.
Applicant's invention involves a vascular access system, known as the Squitieri Hemodialysis and Vascular Access System, which creates a continuous blood flow and which is easily accessed and resistant to clotting. These advantages provide ideal access for long term HD, chemo or blood draws. An example, would be patients who are on coumadin which require weekly blood draws. This new system becomes less painful over time as the skin over the “needle access” site become less sensitive. The veins are spared repeated blood draws which results in vein thrombosis to such a degree that some patients “have no veins left” making routine blood draws impossible.
Among the more relevant prior art patents are U.S. Pat. Nos. 4,898,669; 4,822,341; 5,041,098; and, 4,790,826. None of the foregoing patents disclose a system having the features of this inventions